The present invention relates to an implantable prosthesis and, more particularly, to a prosthesis for soft tissue or muscle defects.
Various prosthetic materials are used to repair and/or reinforce anatomical defects, such as tissue and muscle wall hernias. For example, ventral and inguinal hernias are commonly repaired using a sheet of biocompatible fabric, such as a knitted polypropylene mesh (BARD MESH). Tissue integration with the fabric, such as by tissue ingrowth into the fabric, eventually completes the repair.
In certain procedures, the prosthetic fabric may come into contact with tissue or organs potentially leading to undesirable postoperative adhesions and undesirable tissue attachment between the mesh and the tissue or organs. To avoid such adhesions, a prosthesis that is covered with an adhesion resistant barrier may be used. In the repair of ventral hernias, the prosthesis is positioned with the barrier facing the region of potential adhesion, such as the abdominal viscera. In the case of chest wall reconstruction, the barrier faces the thoracic viscera (i.e., heart and lungs). One example of such a prosthesis is disclosed in U.S. Pat. No. 5,593,441, assigned to C. R. Bard, Inc. Another example of a prosthetic material including an adhesion resistant barrier is disclosed in U.S. Pat. No. 6,120,539, also assigned to C. R. Bard, Inc.
Once inserted into a patient, the prosthesis is typically sutured, stapled or otherwise provisionally anchored in place over, under or within the defect. In some prostheses, such as that described in U.S. Pat. No. 6,267,772, also assigned to C. R. Bard, Inc., antimigration barbs extend from the implantable material to prevent migration of the prosthesis after implantation.
Another issue that is of concern is the correction of defects which occur in tissue or muscle weakened by previous surgery or large defects in tissue or muscle of obese patients. Factors such as obesity, chronic pulmonary disease, prior surgery, wound infection and seroma or hematoma formation continue to exert adverse influences on wound healing and increase the chance of recurrent herniation. Often, the abdominal wall of these patients is severely compromised and weakened such that it will not support a primary correction, and any such closure may be associated with a significant recurrence rate. Other configurations of prostheses can be found in U.S. Pat. Nos. 5,695,525; 5,725,577, 5,743,917, and 6,267,772, each of which is also assigned to C. R. Bard, Inc.
The present invention relates to an implantable prosthesis for an anatomical defect, such as a tissue or muscle defect, that promotes tissue growth into the prosthesis and subsequently strengthens the area of the defect. The prosthesis is easy to manipulate and is designed to minimize the incidence of postoperative adhesions between a portion of the prosthesis and surrounding tissue or organs. In addition, the prosthesis strikes a balance between being sufficiently rigid to aid in manipulation and deployment in the area of desired coverage and sufficiently flexible to be acceptable to both the surgeon and the patient. Further, the prosthesis is constructed to allow it to be provisionally held in place at desired locations until sufficient tissue ingrowth occurs. Embodiments of the prosthesis are particularly suited for correction or repair of large defects, such as those that may occur in obese patients. The prosthesis may include one or more features, each independently or in combination, contributing to such attributes.
In one embodiment, an implantable prosthesis for a tissue or muscle defect includes first and second layers of material that permit the formation of adhesions with tissue or muscle. The second layer is attached to the first layer. At least one pocket is formed between the first and second layers. A layer of barrier material that is resistant to the formation of adhesions with tissue or muscle is attached to at least the second layer.
In one aspect of this embodiment, substantial areas of the second layer are free from attachment to the layer of barrier material. In another aspect, the prosthesis is constructed and arranged to be provisionally attached to the tissue or muscle. In other aspects, the layer of barrier material includes ePTFE and, each of the first and second layers comprises polypropylene mesh.
In another embodiment, an implantable prosthesis for a tissue or muscle defect includes at least one layer of material, at least a portion of which permits the formation of adhesions with tissue or muscle. The at least one layer includes a peripheral edge, an outer area disposed inwardly of the peripheral edge, and an inner area disposed inwardly of the outer area. A pocket is formed in the at least one layer. A first reinforcing member is coupled to the at least one layer, surrounds the outer area and is constructed and arranged to reinforce at least the outer area. A second reinforcing member is inwardly spaced from the first reinforcing member and is coupled to the at least one layer.
In one aspect of this embodiment, each of the first and second reinforcing members is formed in a ring-shaped configuration and in another aspect, the first and second reinforcing members are generally concentric with each other. In yet another aspect, the first and second reinforcing members are sandwiched between first and second layers of material and in still another aspect, the first and second layers of material are stitched together to form a first channel and a second channel, with the first reinforcing member being disposed within the first channel and the second reinforcing member being disposed in the second channel. In yet another aspect, at least a portion of the outer area is constructed and arranged to extend beyond the defect by at least approximately 3 cm, and in still another aspect, the prosthesis includes a surface having an area greater than 50 square cm.
In yet another embodiment, an implantable prosthesis for a tissue or muscle defect includes at least one layer of material, at least a portion of which permits the formation of adhesions with tissue or muscle. The at least one layer includes a peripheral edge, an outer area disposed inwardly of the peripheral edge and an inner area disposed inwardly of the outer area. At least one first pocket is formed in the inner area and at least one second pocket is formed in the outer area separately from the at least one first pocket. The at least one second pocket includes at least one access opening for gaining access to an interior of the at least one second pocket.
In one aspect of this embodiment, the prosthesis includes a partition closing an end of the first pocket and defining a boundary between the at least one first pocket and the at least one second pocket. In another aspect, the partition is constructed and arranged to prevent access from the first pocket to the second pocket. In yet another aspect, the at least one access opening comprises a plurality of spaced openings. In still another aspect, the spaced openings are formed in the first layer of material and in still another aspect, a portion of the first layer of material between the plurality of openings forms a bridge to the inner area. In another aspect, the at least one first pocket is constructed and arranged to receive four fingers of a person implanting the prosthesis.
In still another embodiment, an implantable prosthesis for a tissue or muscle defect includes at least one layer of material, at least a portion of which is susceptible to the formation of adhesions with tissue or muscle. The at least one layer of material includes a first layer of mesh material and a second layer of mesh material attached to the first layer of mesh material. The at least one layer includes a peripheral edge, an outer area disposed inwardly of the peripheral edge and an inner area disposed inwardly of the outer area. At least one first pocket is formed in the inner area and is defined by attachment of the first and second layers of mesh material. At least one second pocket is formed in the outer area and is defined by attachment of the first and second layers of mesh material. The at least one second pocket is separate from the at least one first pocket. Each of the at least one first and second pockets includes an access opening for gaining access to an interior of the respective at least one pocket. A first reinforcing member is coupled to the at least one layer, substantially surrounds the outer area and is constructed and arranged to reinforce at least the outer area. A second reinforcing member is inwardly spaced from the first reinforcing member and is coupled to the at least one layer.
In another embodiment, an implantable prosthesis for a tissue or muscle defect includes at least one layer of material, at least a portion of which is susceptible to the formation of adhesions with tissue or muscle. The at least one layer of material includes a first layer of mesh material and a second layer of mesh material attached to the first layer of mesh material. The at least one layer includes a peripheral edge, an outer area disposed inwardly of the peripheral edge and an inner area disposed inwardly of the outer area. A barrier layer that substantially inhibits the formation of adhesions with tissue is attached to at least the second layer of mesh material. At least one first pocket is formed in the inner area and is defined by attachment of the first and second layers of mesh material. At least one second pocket is formed in the outer area and is defined by attachment of the first and second layers of mesh material. The at least one second pocket is separate from the at least one first pocket. Each of the at least one first and second pockets includes an access opening for gaining access to an interior of the respective at least one pocket. A first reinforcing member is coupled to the at least one layer, substantially surrounds the outer area and is constructed and arranged to reinforce at least the outer area. A second reinforcing member is inwardly spaced from the first reinforcing member and is coupled to the at least one layer.
Various embodiments of the present invention provide certain advantages and overcome certain drawbacks of prior prostheses. Embodiments of the invention may not share the same advantages, and those that do may not share them under all circumstances. This being said, the present invention provides numerous advantages including the noted advantages of ease of implantation and promotion of desired tissue or muscle growth without involving surrounding tissue or organs.
Further features and advantages of the present invention, as well as the structure of various embodiments, are described in detail below with reference to the accompanying drawings.